Diabetes Mellitus (DM) is a fast growing epidemic disease (Centers for Disease Control and Prevention, National Diabetes Fact Sheet, 2011). 29.1 million children and adults in the U.S. have DM, (9.3% of the population)(American Diabetes Association, Fast facts: data and statistics about diabetes, Revision March 2013; Centers for Disease Control and Prevention. Diabetes report card 2012: National state profile of Diabetes and its Complications, August 2012) with 21 million people being diagnosed with DM and 8.1 million people being undiagnosed (Centers for Disease Control and Prevention, Diabetes report card 2012: National state profile of Diabetes and its Complications, August 2012; Centers for Disease Control and Prevention, Department of Health and Human Services, National Diabetes Statistics Report. 2014 National Diabetes data fact sheet). Eighty-six million people are classified as pre-diabetic. DM is defined by fasting hyperglycemia >200 mg/dL Hyperglycemia occurs when the body produces low levels of insulin or the insulin produced is deficient. DM can be classified as: (1) Type 1 Diabetes Mellitus (T1DM) where the body produced no insulin by failure at the beta cells of the islets of Langerhans in the pancreas, which can affect adults and children (Genuth et al., Diabetes Care 2003, 26:3160-67; WHO/IDF. Definition and Diagnosis of DM and Intermediate Hyperglycemia. WHO 2006, 21) (2) Type 2 Diabetes Mellitus (T2DM) caused by an insufficient production of insulin by the pancreas, beta cells, and an insulin resistance by the cells specifically in the liver, the muscles and the fat tissue, either existing in the presence of normal insulin levels (Genuth et al., Diabetes Care 2003, 26:3160-67; WHO/IDF. Definition and Diagnosis of DM and Intermediate Hyperglycemia. WHO 2006, 21; Vijan, Annals of Internal Medicine, 2010, 2:150(5)) and (3) Diabetes Gestational (GDM), which is a condition exhibited in pregnant women wherein they develop high blood glucose levels during pregnancy, especially during the third trimester (Moore et al., Medscape, Jul. 7, 2014). The screening for DM and Pre-Diabetes are the primary goals for diabetes care (U.S. Preventive Services Task Force. Screening for type 2 diabetes mellitus in adults. Recommendation statement, Published June 2008).
Hypertension and dyslipidemia are clear risk factor for Cardio Vascular Disease (CVD) and DM (Lopez-Jaramillo et al., Diabetology & Metabolic Syndrome, 2014, 6:31). CVD is the major causes of morbidity and mortality for individuals with DM. Glucose is a key parameter for control of DM. DM can be diagnosed with two basic lab tests: (1) Fasting plasma glucose level at or above 7.0 mMol/L (126 mg/dL) and (2) Glycate haemoglobin (HgbA1c) at or above 6.5. Pre-diabetes is defined as a condition in which individuals have blood glucose and HgbA1c levels higher than normal, but not high enough to be classified as diabetes. The formation of HbA1c is mainly dependent on the interaction between blood glucose concentration and the life span of red blood cells (RBC). Glycated hemoglobin can be directly proportional to a time-averaged concentration of glucose within the red blood cell, and the fact that HbA1c accumulates through the red cell's life-span, which explains why young red cells have lower amounts of HbA1c than old red cells (Bunn et al., The Journal of Clinical Investigation 1976, 57:1652-59). HgbA1c reflects the average of blood glucose level for last 2-3 months, the daily fluctuations of the glucose level cannot affect the HgbA1c levels, and is a more accurate index for diagnosis and long-term monitoring and control for the DM.
There remains a need for additional devices, sensors, and methods for detecting glycated hemoglobin.